Drug reference
Treatment of advanced soft-tissue sarcoma when treatment with anthracyclines and ifosfamide has failed or is contra-indicated | Treatment of relapsed platinum- sensitive ovarian cancer (in combination with pegylated liposomal doxorubicin) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols)
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Elevated creatine phosphokinase (consult product literature)
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NICE decisions ▶Trabectedin for the treatment of advanced soft tissue sarcoma (February 2010) NICE TA185 Trabectedin (Yondelis ®) is an option for advanced soft tissue sarcoma when treatment with anthracyclines and ifosfamide has failed, is inappropriate or is not tolerated. The cost of trabectedin for treatment after the fifth cycle is met by the manufacturer. www.nice.org.uk/guidance/ta185 ▶Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) NICE TA389 Trabectedin (Yondelis ®) in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) is not recommended for treating the first recurrence of platinum-sensitive ovarian cancer. Patients currently receiving trabectedin in combination with PLDH should have the option to continue their treatment until they or their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta389 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2210 The Scottish Medicines Consortium has advised (December 2019) that trabectedin (Yondelis ®) is not recommended for use within NHS Scotland for the treatment of adults with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents, as the clinical and economic case was not demonstrated.
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→Appendix 1: trabectedin
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▶Common or very common Alopecia. anaemia. appetite decreased. arthralgia. asthenia. back pain. constipation. cough. dehydration. diarrhoea. dizziness. dyspnoea. fever. flushing. gastrointestinal discomfort. headache. hyperbilirubinaemia. hypersensitivity. hypokalaemia. hypotension. infection. insomnia. leucopenia. mucositis. myalgia. nausea. neutropenia. oedema. paraesthesia. peripheral neuropathy. skin reactions. stomatitis. taste altered. thrombocytopenia. vomiting. weight decreased ▶Uncommon Capillary leak syndrome. septic shock ▶Rare or very rare Hepatic failure ▶Frequency not known Extravasation necrosis. rhabdomyolysis SIDE-EFFECTS, FURTHER INFORMATION A corticosteroid, such as dexamethasone by intravenous infusion, must be given 30 minutes before therapy for its antiemetic and hepatoprotective effects (consult product literature).
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Effective contraception recommended during and for at least 3 months after treatment in women and during and for at least 5 months after treatment in men.
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See Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid breast- feeding during and for 3 months after treatment.
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Manufacturer advises caution (risk of increased exposure). Dose adjustments Manufacturer advises consider dose reduction.
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Avoid monotherapy if creatinine clearance less than 30 mL/minute. Avoid combination regimens if creatinine clearance less than 60 mL/minute.
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▶Specific haematological, renal and hepatic parameters must be monitored and within certain ranges prior to starting treatment and repeated weekly during the first 2 cycles and at least once between treatments in subsequent cycles—consult product literature for full details. Immune system and malignant disease ▶Monitor for signs and symptoms of rhabdomyolysis (including myelotoxicity, severe liver function disorder, renal failure, muscle weakness or pain)—monitor creatine phosphokinase closely and discontinue treatment (consult product literature).
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Yondelis (Pharma Mar, S.A.) Trabectedin 250 microgram Yondelis 0.25mg powder for concentrate for solution for infusion vials | 1 vial P £363.00 (Hospital only) Trabectedin 1 mg Yondelis 1mg powder for concentrate for solution for infusion vials | 1 vial P £1,366.00 (Hospital only) ANTINEOPLASTIC DRUGS › PLATINUM COMPOUNDS
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(consult product literature or local protocols)
First-line fragment. Read the complete Indications and Dose section above.
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